Johnnique Harris - Quality Assurance Specialist, Merck

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Work Background

MerckSpecialist, Quality Assurance

Oct. 2024Durham, North Carolina, United StatesSupports the deviation management program including the coordination of managing Quality Notifications (QNs) in SAP to assess product impact and effective corrective actions and review of investigations. • Review of various records impacting batch release. • Serve as a technical subject matter expert (SME) in selected quality systems • Provides support to Production and QC activities by ensuring released media and raw materials are available, including weekends as required • Executes Walkthrough audits of the GMP areas of the site on a routine basis. • Work closely with quality and other departments to ensure appropriate root cause and CAPAs are determined . • Author/revise SOPs, methods, protocols, and trend reports. • Provide support to all Quality related audits from external and regulatory agencies. • Participate in Quality Risk Assessments and serve as QA SME • Review and approve validation reports • Identify Continuous Process Improvements to maximize efficiencies and streamline processes within Quality.

Beam TherapeuticsSenior Specialist, Quality Assurance Operations

Jul. 2022 - Sep. 2023Durham, North Carolina, United States1. Partner cross functionally with other areas of the business to provide oversight of site start-up activities, conduct quality risk management, encourage continuous improvement, and scale-up activities at Beam NC facility. 2. Provide QC operations oversight and quality oversight of floor activities including plant presence during operations. 3. Ensure cGMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations. 4. Responsible for assisting with product disposition activities of supply produced at the manufacturing facility including Review of batch records and labels, Review and approval of manufacturing discrepancies, laboratory investigations, and change controls, and Communicating lot disposition pending issues as required. 5. Develop and oversee improvement of applicable quality systems at Beam NC by identifying gaps or improvements, authoring and approving procedures, and providing training. 6. Review and approve validation protocols, calibration and maintenance work orders and asset inductions. 7. Provide QA support for resolution of material, product, environmental, facility and equipment manufacturing issues. 8. Support functional and facility goals and objectives. 9. Support and contribute to quality metrics for the facility. 10. Responsible for supporting and participating in regulatory inspections. Responsible for communicating escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or the company brand image to senior management.

Novo NordiskQuality Improvement Area Specialist

Jul. 2018 - Jul. 2022Clayton, North CarolinaCollaborate with a cross functional team of Quality Improvement Area Specialists, Process Analysts, Engineers, Shift leaders, and Quality professionals to ensure safe and effective medicines are produced and distributed to meet customer needs. Demonstrate understanding of customer (internal/external) requirements by communicating expectations and building relationships, while modeling a Quality Mindset. 1. Responsible for the investigation of deviations in the Diabetes Finished Production (DFP) department 2. Respond to calls from production to conduct initial problem perception relating to deviation classification 3. Initiate, draft, and route deviations in the novoGlow electronic system to process for closure and meet lead time Key Performance Indicators (KPI’s) 4. Encourage a continuous improvement culture by ensuring Batch Production Records (BPR’s) are accurate and completed in a timely fashion 5. Work with stakeholders to find preventive actions to eliminate re-occurrence of deviations 6. Ensure compliance with training programs and confirm appropriate curriculum have been assigned 7. Execute process confirmation of standards utilized and work with team members to improve quality and compliance 8. Ensure that corrective actions from investigations have been actively communicated to team members 9. Perform assessments of Audit Readiness periodically in DFP process areas (Assembly, Packaging)

GSKQuality Improvement Practitioner

Jun. 2015 - Aug. 2017Raleigh-Durham, North Carolina Area1. Strengthen Continuous Improvement culture by providing hands on leadership 2. Perform Inspection Readiness and Level 2 audits within facility including Manufacturing, Packaging, and Laboratory areas to ensure preparedness for external audits 3. Provide shop floor support related to Quality issues or atypical occurrences 4. Interface with department management to embed a Quality culture site wide 5. Facilitate RCA problem solving 6. Conduct trainings cross functionally (eDM, Human Factors) 7. Conduct GEMBAs across value streams 8. Manage logbooks process site wide by standardizing the process across value streams (Issuance, Use, Maintenance, Review, and Archival)

Depuy SynthesFDA Compliance and Quality Consultant Complaint Specialist II (Maetrics LLC)

Jan. 2013 - Feb. 2015West Chester, Pennsylvania1. Complaint Specialist responsible for supporting Post Market Regulatory Affairs activities associated with Complaint Handling and MedWatch submissions in the Medical Devices industry 2. Report and Review Initial and Supplemental MedWatch Reports (3500A) and submit to FDA 3. Responsible for ensuring that technical evaluations and investigational tasks required for the complaint investigation process are completed

HospiraInvestigative Writer Supplier Quality (Kelly Services)

Jul. 2012 - Jan. 2013Rocky Mount, North Carolina Area1. Conduct and write formal investigation reports 2. Perform impact risk assessment, determine root cause, initiate appropriate corrective and preventative actions 3. Track and trend within Trackwise® system to detect reoccurrence of supplier/vendor nonconformance’s 5. Plan, coordinate, and execute investigation activities from initiation to completion of investigation report 6. Conduct investigations to identify root cause and implement effective solutions (corrective and preventive action) for quality systems and customer complaints

Sandoz PharmaceuticalsBusiness Process Analyst

Jan. 2011 - Jul. 2012Wilson, North Carolina1. Identify continuous improvement needs 2. Conduct operational and performance qualification testing of new systems and / or processes for implementation 3. Build MES computer system to encompass current manufacturing practices 4. Write and revise Standard Operating Procedures (SOPs) as required to comply with changes

Sandoz PharmaceuticalsPackaging Technician, Lead Technician, CAPA Coordinator, Project Management

Apr. 2003 - Jan. 2011Wilson, North CarolinaTen plus years of pharmaceutical industry experience in the areas of Packaging, Manufacturing, Compliance, Quality Assurance Documentation, and Project Management. 1. Project Manager on remediation project to rewrite Formulation Manufacturing Records (FMRs) for the manufacturing department. 2. Interfaced with Packaging and Manufacturing departments to complete Investigations, CAPAs, and Change Controls related to Packaging and Manufacturing equipment. 3. Developed training presentations to support Six Sigma activities and new equipment introduction. 4. Conducted batch record reviews to verify proper execution of FMR steps and data entry. 5. Conducted installation, operational, and performance qualification (IQ, OQ, & PQ) testing of new systems and processes. 6. Trained employees on TrackWise® system use for CAPAs, Investigations, and Change Controls. 7. Successful migration of over 1,000 SOPs into the Sandoz Document Management System (SDMS) to monitor revision and approval of SOPs.

Manpower / MotherHood MaternityCustomer Service / Production

Dec. 2001 - Apr. 2003Rocky Mount, North Carolina, United StatesManpower Cashiering, stock replenishment, Store management ( key holder), and meeting production standards on various short term assignments.

HospiraPackaging Technician

Sep. 1999 - Oct. 2001Rocky Mount, North Carolina Area1. Responsible for the inspection of bottles and vials for any type of foreign particulate 2. Responsible for labeling and packaging of manufactured product 3. Served as line trainer for new employees 4. Responsible for trouble shooting all line equipment